Assistant Manager Quality Assurance- Pharma

Major Responsibilities:

Ø  Quality Management System Implementation and Modification control.

Ø  Document Control.

Ø  Approval for batch release.

Ø  Review and approval of Qualification Document.

Ø  Review and approval of Calibration and Validation document.

Ø  Planning, execution and compliance of both internal and external audits.

Ø  Preparation of audit compliance report.

Job description

Minor Responsibilities:

Ø  Review and approval of SMF, VMP and Quality manual.

Ø  Review and approval of BMR, BPR, MFC.

Ø  Review and approval of OOS/OOT.

Ø  Review and approval of Vendor list.

Ø  Planning, execution and compliance of both internal and externalaudits.

Ø  Review and approval   of all Quality Assurance, quality Control and manufacturing records.

Ø  Review of filled BMR/BPR and analysis data, and release of batch for dispatch.

Ø  Review and approval of SOPs.

Ø  To prepare audit and compliance reports and CAPA reports.

Ø  Review and approval of Qualification Documents.

Ø  To review and approval of Change control.

Ø  Review and approval of Deviation, Incidence.

Ø  Review and approval of APQR.

Ø  Review and approval of Method of analysis, Specification, Stability report, Technology transfer and Modification of area.

Ø  Review and approval of hold time study protocol and report.

Ø  Review, approval and Implementation of CAPA.

Ø  To review, assessment and closer of market complaint and product recall.

Ø  Review of pest control and rodent control.

Ø  Training.

Ø  To handle all regulatory, FDA and cGMP audits of customer.

Ø  Review the documents and data control.

Ø  Review and approval of all validation documents.

Ø  To review, monitor IPQA activities.